6 Colo. Code Regs. § 1007-1-2.8

Current through Register Vol. 47, No. 11, June 10, 2024

Section 6 CCR 1007-1-2.8 - Out-of-State Radiation Machines

2.8.1 Subject to these regulations, any person who desires to bring radiation machines into this state for temporary use is hereby granted authorization to conduct activities using these machines for a period not to exceed a total of 180 days in any calendar year, provided that:

2.8.1.1 The out-of-state registration, and/or other documents authorizing the use of radiation machines issued by the agency having jurisdiction where the out-of-state registrant maintains an office for directing the registered activity and at which radiation safety records are normally maintained, does not limit the activity authorized by such document to specified installations or locations; and

2.8.1.2 The person proposing to bring such machines into Colorado shall give written notice to the Department at least fifteen (15) calendar days before such machine is to be used in the state, unless otherwise authorized by the Department as provided in 2.8.2. The notice shall be made using the Department's "X-ray Reciprocity Request" Form R-200 and shall include all information required by that form.

(1) As part of this notice, the person requesting reciprocity shall certify that:

(a) A copy of all applicable parts of these regulations shall be available at each use location in State of Colorado;

(b) Each machine has been evaluated and determined to be in compliance with these, or equivalent, regulations; and

(c) The operation of each radiation machine shall be in accordance with the applicable requirements of these regulations.

(2) In the case of a request to perform a healing arts screening program within the State, submit a completed Form R-300, "Application for Registration - Healing Arts Screening," with the reciprocity request, including all of the information required, pursuant to Part 6, Appendix 6F, by the form and any accompanying instructions.

(3) In the case of a request to perform mammography screening within the State, a copy of the facility's mammography certificate issued by the FDA ( 21 CFR Part 900.11(a) ) and applicable American College of Radiology credentials shall be included with the reciprocity request.

(4) The person requesting reciprocity shall also supply such other information as the Department may request.

2.8.1.3 The out-of-state registrant complies with all applicable regulations of the Department; and

2.8.1.4 The out-of-state registrant shall at all times during work at any work location within the State have available the pertinent documentation as required by these regulations, including:

(1) Pertinent registration documentation;

(2) Written authorization from the Department for in-state activities;

(3) Applicable sections of these regulations as certified pursuant to 2.8.1.2(1)(a);

(4) Documentation that each radiation machine has been evaluated in accordance with these regulations, or other state regulations which are equivalent; and that

(a) The machines comply with the manufacturer's required specifications;

(b) The evaluations are current, having been performed within one year prior to entry into the State as required in 2.5; and

(5) In the case of mammography-related functions, a copy of the mammography certificate issued by the FDA, applicable American College of Radiology credentials, quality control records, personnel records, and the most recent medical physicist survey.

2.8.2 Based upon an application that includes documentation of why it is not possible or is an undue hardship to provide fifteen (15) calendar days notice, the Department may:

2.8.2.1 Grant permission to proceed sooner; or

2.8.2.2 Waive the requirement for filing additional written notifications during the remainder of the calendar year following the receipt of the initial notification from a person engaging in activities pursuant to 2.8.1.

2.8.3 While in the State of Colorado, all radiation machines are subject to inspection and may require a certification evaluation by a qualified inspector who is registered with the Department.

2.8.4 The out-of-state registrant shall notify the Department within one hour after arrival at the actual work location within the State and shall notify the Department within one hour after any change of work location within the State.

2.8.5 If multiple individuals work concurrently at more than one work location under an approval granted pursuant to 2.8.1, each day worked per location shall be counted separately toward the limit of 180 cumulative total days per calendar year.

2.8.6 The Department may revoke, limit, or qualify its approval for the use of radiation machines in the State upon determining that the approval was based on false or misleading information submitted to the Department or that such action is necessary in order to prevent undue hazard to public health and safety or property.

2.8.7 Each person operating a radiation machine within the State under reciprocity in areas of exclusive federal jurisdiction shall comply with the applicable federal requirements.

6 CCR 1007-1-2.8

Colorado Register, Vol 37, No. 14. July 25, 2014, effective 8/14/2014

38 CR 02, January 25, 2015, effective 2/14/2015

38 CR 05, March 10, 2015, effective 3/30/2015

38 CR 12, June 25, 2015, effective 7/15/2015

38 CR 14, July 25, 2015, effective 8/14/2015

39 CR 02, January 25, 2016, effective 2/14/2016

39 CR 16, August 25, 2016, effective 9/14/2016

39 CR 22, November 25, 2016, effective 12/15/2016

40 CR 11, June 10, 2017, effective 6/30/2017

40 CR 20, October 25, 2017, effective 11/14/2017

42 CR 24, December 25, 2019, effective 1/14/2020

43 CR 14, July 25, 2020, effective 8/14/2020

43 CR 18, September 25, 2020, effective 10/15/2020

44 CR 11, June 10, 2021, effective 7/15/2021

44 CR 14, July 25, 2021, effective 8/14/2021

45 CR 22, November 25, 2022, effective 12/15/2022

47 CR 06, March 25, 2024, effective 4/14/2024